MalfunctionKQC
COULTER TRUCOLOR WRIGHT GIEMSA STAIN
Received Feb 1, 2012 · Event occurred Jan 5, 2012
Report 1061932-2012-00207 · MDR key 2434606
Device
Generic name
Stains, Hematology
Manufacturer
Beckman Coulter, Inc.Catalog number
A50832
Lot number
0633783
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
BECKMAN COULTER, INC. (BEC) PERSONNEL REPORTED THAT FOUR BOTTLES OF COULTER TRUCOLOR WRIGHT-GIEMSA STAIN WERE FOUND TO BE LEAKING A SMALL AMOUNT OF STAIN AROUND THE CAPS UPON ARRIVAL AT THE LAB. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.
Additional Manufacturer Narrative
(B)(4).